Congressman August Pfluger (TX-11) and Congressman Dan Crenshaw (TX-2) led over 50 of their Republican colleagues in sending a letter to Biden Administration officials decrying the lack of COVID-19 therapeutic availability, including monoclonal antibody treatments.

“Rather than following the successful model that the Trump Administration laid out under Operation Warp Speed and utilizing ASPR authorities, the Administration focused their efforts solely on constantly changing masking requirements and vaccine education campaigns,” the Members wrote. “As a result, we are suffering from an embarrassingly low supply of effective therapies because of the Administration’s poor judgement and planning since February 2021.”

Read the full letter here or below.

January 22, 2022

Dawn O’Connell, J.D.

Assistant Secretary for Preparedness and Response Department of Health and Human Services Washington, D.C.

David Kessler, M.D. Chief Science Officer

COVID-19 Response Team White House

Washington, D.C.

Dear Ms. O’Connell and Dr. Kessler,

We write today concerning the lack of supply of COVID-19 therapeutics, including monoclonal antibody treatments, in our respective states. The scarcity of these effective treatments must be addressed immediately so our communities have the appropriate tools needed to combat COVID- 19.

The country is in the middle of an Omicron surge, a new but not unexpected variant of COVID- 19 given the emergence of many other variants of concern during the pandemic. There are multiple outpatient treatments for COVID-19: two oral antivirals, one antiviral, and four monoclonal treatments, including a new pre-exposure antibody treatment.

Rather than following the successful model that the Trump Administration laid out under Operation Warp Speed and utilizing ASPR authorities, the Administration focused their efforts solely on constantly changing masking requirements and vaccine education campaigns. As a result, we are suffering from an embarrassingly low supply of effective therapies because of the Administration’s poor judgement and planning since February 2021.

Please provide, in writing, answers to the below questions:

1. How many contracts for Sotrovimab have been signed as of the date of the letter? Include the following information about each contract in your response:
   1. The value of each contract, including the number of courses and doses purchased and their costs respectively;
   2. The number of contract options, including whether the options have been exercised or declined;
   3. The dates of allocation and delivery of Sotrovimab doses under each contract, including future allocations;

2. Please provide a list of all COVID-19 therapeutic candidates the federal government has invested in since January 20, 2021. Do not include in your response therapeutic candidates for which government funding was provided before January 20, 2021.

3. What actions has the Biden Administration taken to prepare for anticipated new variants?
   1. Please list and describe the programs in place to support the development of new therapeutics including monoclonal antibodies, polyclonal antibodies, and other therapeutics.
   2. Please list and describe contracts in place to expand the scope of government purchases of oral antiviral treatments.
   3. Given the challenges the current limited supply of COVID-19 therapeutics is causing, identify what actions are being taken to prevent and mitigate future supply constraints of monoclonal antibodies and oral antivirals.

4. The Biden Administration decided in early-2021 to dismantle Operation Warp Speed and transition its responsibilities to HHS. Last month, the non-partisan Government Accountability Office reported that HHS had failed to meet major milestones for the transition and was not prepared to assume Operation Warp Speed’s responsibilities. This is extremely troubling.
   1. What is the Biden Administration’s plan for therapeutics, testing, and vaccine development now that it has dismantled Operation Warp Speed?
   2. Please provide copies of the Administration’s plans if they exist.

5. Many of our existing COVID-19 therapeutics are ineffective against the Omicron variant. Given the high rate of mutation common in the coronaviridae family, the Administration should have foreseen a situation in which existing therapeutics would be ineffective against new variants.
   1. What was the Administration’s strategy for the development and deployment of new therapeutics?
   2. Please identify how the Administration will update and/or develop a comprehensive COVID-19 therapeutic strategy for new variants, incorporating lessons learned from the emergence of the Omicron, Delta, and other variants of concern.

We look forward to your timely response on this important matter, as well your support for our respective states’ requests for additional supplies.

Sincerely,

Dan Crenshaw, August Pfluger, Elise Stefanik, Cathy McMorris Rodgers, Tom Emmer, Kevin Brady, Virginia Foxx, Jason Smith, Rodney Davis, Michael McCaul, Brett Guthrie, Fred Upton, H. Morgan Griffith, David B. McKinley, P.E., Gus M. Bilirakis, Robert E. Latta, Tom Cole, Michael C. Burgess, M.D., John Joyce, M.D., Larry Buschon, M.D., Neal P. Dunn, M.D., Tim Walberg, Jeff Duncan, Richard Hudson, Billy Long, Greg Pence, Earl L. “Buddy” Carter, Markwayne Mullin, Debbie Lesko, Kelly Armstrong, John R. Curtis, Bill Johnson, Jackie Walorski, Adrian Smith, Jodey C. Arrington, Mike Kelly, Carol D. Miller, Brad R. Wenstrup, D.P.M., Steve Womack, David Joyce, Michael Guest, Daniel Webster, Robert Wittman, William R. Timmons, IV, Roger Williams, Beth Van Duyne, Mariannette J. Miller-Meeks, M.D., Bill Posey, Randy Feenstra, Ronny Jackson, M.D., Brian Babin, D.D.S., Darrell Issa, Scott DesJarlais, Nicole Malliotakis, Christopher H. Smith.